What is a Pragmatic Clinical Trial?
Section 6
Key Considerations for PCTs
Planning an ePCT often requires different approaches to study design, stakeholder engagement, start-up, data collection, data analysis, ethical oversight, and dissemination than do traditional RCTs (O’Rourke et al. 2015). To provide expertise and support to the NIH Collaboratory Trials, several working groups, or Cores, were established to assist study teams as they navigate from planning to implementation. The webpage for each Core listed below provides information and links to multiple resources including webinars, publications, and white papers that reflect the knowledge, insight, and best practices acquired by the Cores in collaboration with the NIH Collaboratory Trials.
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REFERENCES
O’Rourke PP, Carrithers J, Patrick-Lake B, et al. 2015. Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials. 12:449–456. doi:10.1177/1740774515597685. PMID: 26374678.